Several devices have been designed for MRI-guided breast biopsies. U.S. Pat. No. 6,675,037 issued to Nikolaos V. Tsekos on Jan. 6, 2004 titled “MRI-guided interventional mammary procedures” and is incorporated herein by reference. Tsekos discloses a remotely controlled apparatus for MR-guided interventional procedures with four positional degrees of freedom to deliver a probe to a target location within the breast. The apparatus allows the practice of a method that provides flexibility in conditioning the breast, i.e., orientation and degree of compression, and in setting the trajectory of the intervention. To that end, a conditioning/positioning device, fitted with the appropriate degrees of freedom, provides the means for interventional procedures. Remote control of this device can allow planning the operation and performing the relevant tasks in a short period, for example, within the contrast window provided by a single injection of a contrast agent.
U.S. Pat. No. 6,558,337 titled “Positioner for medical devices such as biopsy needles” issued to Dvorak et al. May 6, 2003 and is incorporated herein by reference. Dvorak et al. disclose a similar device with a slightly different method for determining a declination angle of the probe. However, both of these designs are built upon using only bilateral compression plates to stabilize the breast. Not only does this limit access to the breast, there may be movement of the target between uncompressed and compressed states, thereby requiring repositioning and reimaging.
A paper by Blake T. Larson, Nikolaos V. Tsekos, and Arthur G. Erdman, “A Robotic Device For Minimally Invasive Breast Interventions With Real-Time MRI Guidance” (Proceedings of the IEEE 3rd International Symposium on Bioinformatics and Bioengineering (BIBE2003), IEEE, pages 190-197), is hereby incorporated by reference. This paper describes a device to perform minimally invasive interventions in the breast with real-time MRI guidance for the early detection and treatment of breast cancer. The device uses five computer-controlled degrees of freedom to perform minimally invasive interventions inside a closed MRI scanner. Typically the intervention would consist of a biopsy of the suspicious lesion for diagnosis, but may involve therapies to destroy or remove malignant tissue in the breast. The procedure proceeds with: (a) conditioning of the breast along a prescribed orientation, (b) definition of an insertion vector by its height and pitch angle, and (c) insertion into the breast. The entire device is made of materials compatible with MRI, avoiding artifacts and distortion of the local magnetic field. The device is remotely controlled via a graphical user interface. This is the first surgical robotic device to perform real-time MRI-guided breast interventions in the United States.
A paper by Blake T. Larson, Nikolaos V. Tsekos, Arthur G. Erdman, Essa Yacoub, Panagiotis V. Tsekos, and Ioannis G. Koutlas, “DESIGN OF A ROBOTIC STEREOTACTIC DEVICE FOR BIOPSY AND MINIMALLY INVASIVE INTERVENTIONS IN THE BREAST WITH REAL TIME MRI GUIDANCE” (Proceedings of DETC'02: ASME 2002 Design Engineering Technical Conferences and Computers and Information in Engineering Conference, Montreal, Canada, September 29-Oct. 2, 2002 (DETC2002/MECH-34286)), is hereby incorporated by reference. This paper described a robotic device to perform biopsy and therapeutic interventions in the breast with real-time MRI guidance. The device used parallel-plate bilateral compression plates to flatten and immobilize the breast of the patient. The device was designed to allow for (i) conditioning of the breast by compression, (ii) definition of the interventional probe trajectory, by setting the height and pitch of a probe insertion apparatus, and (iii) positioning of an interventional probe by setting the depth of insertion. The apparatus was fitted with five computer-controlled degrees of freedom for delivering an interventional procedure. The apparatus was remotely controlled by means of ultrasonic actuators and a graphical user interface, providing real-time MRI-guided planning and monitoring of the operation.
A 2004 paper by Blake T. Larson, Nikolaos V. Tsekos, Essa Yacoub, Panagiotis V. Tsekos, Ioannis G. Koutlas, “Design of an MRI-Compatible Robotic Stereotactic Device for Minimally Invasive Interventions in the Breast” (Journal of Biomechanical Engineering, Transactions of the ASME, AUGUST 2004, Vol. 126, pages 459-465), is hereby incorporated by reference. This paper described a robotic device to perform biopsy and therapeutic interventions in the breast with real-time magnetic-resonance-imaging (MRI) guidance. The device was designed to allow for (i) stabilization of the breast by compression, (ii) definition of the interventional probe trajectory by setting the height and pitch of a probe insertion apparatus, and (iii) positioning of an interventional probe by setting the depth of insertion. The apparatus is fitted with five computer-controlled degrees of freedom for delivering an interventional procedure. The apparatus is remotely controlled by means of ultrasonic motors and a graphical user interface, providing real-time MRI-guided planning and monitoring of the operation. Joint-motion measurements found probe placement in less than 50 s and sub-millimeter repeatability of the probe tip for same-direction point-to-point movements. However, backlash in the rotation joint may incur probe-tip-positional errors of up to 5 mm at a distance of 40 mm from the rotation axis, which may occur for women with large breasts. The imprecision caused by this backlash becomes negligible as the probe tip nears the rotation axis. Real-time MRI-guidance would allow the physician to correct this error. Compatibility of the device within the MRI environment was successfully tested on a 4-Tesla MRI human scanner.
Other conventional MRI-compatible devices include: W. A. Kaiser, H. Fischer, J. Vagner, and M. Selid, “Robotic system for biopsy and therapy of breast lesions in a high-field whole-body magnetic resonance tomography unit,” Investigative Radiology, vol. 35, pp. 513-519, August 2000 (which is incorporated herein by reference), which describes an apparatus with a limited range of motion.
What is needed is an improved motor-controlled positioning and actuating system for performing medical procedures, and in some embodiments, in particular such a system that is compatible for use within a high-magnetic-field environment such as an MRI (magnetic-resonance-imaging) machine.